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FDA 510(k)

Straumann PURE Ceramic Implants

K-Number: K171769 · 2017-11-14

ApplicantStraumann USA, LLC (On Behalf of Institut Straumann Ag)
Decision Date2017-11-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann PURE Ceramic Implants is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA, LLC (On Behalf of Institut Straumann Ag). It received FDA 510(k) clearance on 2017-11-14 under 510(k) number K171769. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Straumann PURE Ceramic Implants?

Straumann PURE Ceramic Implants is a medical device that received FDA 510(k) clearance on 2017-11-14. The listed applicant is Straumann USA, LLC (On Behalf of Institut Straumann Ag). The 510(k) number is K171769.

When did Straumann PURE Ceramic Implants receive FDA 510(k) clearance?

Straumann PURE Ceramic Implants received FDA 510(k) clearance on 2017-11-14, under 510(k) number K171769.

Who is the listed applicant for Straumann PURE Ceramic Implants?

The FDA 510(k) record lists Straumann USA, LLC (On Behalf of Institut Straumann Ag) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Straumann PURE Ceramic Implants?

The FDA product code for Straumann PURE Ceramic Implants is DZE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03908177Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT.COMPLETED

Other records listing Straumann USA, LLC (On Behalf of Institut Straumann Ag) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200597Straumann BLX Gold AbutmentsK171757Straumann Screw Retained Abutments

Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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